BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2131710 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04269
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). DIL CATH: APEX 2.5 X 15, 3.5 X 15 VOYAGER. OTHER: EXPORT CATHETER, ASPIRIN, HEPARIN, PLAVIX. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, THROMBOSIS, STENOSIS, AND VENTRICULAR ARRHYTHMIA ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN ST ELEVATION MYOCARDIAL INFARCTION AND WAS FOUND TO HAVE A 100% OCCLUDED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT SHOWED A FILLING DEFECT CONSISTENT WITH THROMBUS AT THE SITE OF THE OCCLUSION. THE LESION WAS PREDILATED AND THE THROMBUS WAS ASPIRATED WITH NON-ABBOTT DEVICES. THE 3.5X15 XIENCE V WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION AND BRISK DISTAL FLOW WAS CONFIRMED. APPROXIMATELY FIFTEEN MINUTES LATER, THE PATIENT EXPERIENCED CHEST PAIN AND THE EKG SHOWED ST ELEVATION IN MULTIPLE LEADS. A REPEAT CORONARY ANGIOGRAM REVEALED 100% IN-STENT THROMBOSIS AT THE PLAD. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION THAT WAS SUCCESSFULLY TREATED WITH DEFIBRILLATION. THE PATIENT WENT ON TO HAVE THE THROMBUS ASPIRATED WITH A NON-ABBOTT CATHETER. THE LESION WAS PREDILATED WITH A 2.5 X 15 VOYAGER AND TWO XIENCE V STENTS WERE IMPLANTED; A 3.0 X 8 XIENCE AT THE DISTAL END OF THE PREVIOUSLY DEPLOYED 3.5X15 XIENCE V AND A 3.5 X 8 XIENCE V AT THE PROXIMAL EDGE OF THE 3.5X15 XIENCE V. THE PATIENT AGAIN WAS FOUND TO HAVE BRISK FLOW. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062441

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R